June 17, 1996
Lilly's Humalog -- First New Insulin in 14 Years -- Approved for Marketing by U.S. Food and Drug Adminstration
INDIANAPOLIS -- The U.S. Food and Drug Administration has granted Eli Lilly and Company permission to market Humalog® (insulin lispro [rDNA origin]) for the treatment of diabetes mellitus. The agency's action makes the U.S. the 21st country in which Humalog has been approved for marketing.
Humalog is a new type of insulin that more closely mimics the body's natural rapid insulin output after eating a meal. The agency approved Humalog for marketing in the United States after reviewing clinical data from multinational studies that were submitted to the FDA by Lilly in March 1995.
"As the first new insulin in more than a decade, Humalog represents a significant step forward for Lilly and the state of diabetes care," said Richard DiMarchi, vice president of endocrine research at Lilly Research Laboratories in Indianapolis. "Humalog will give people with diabetes an additional resource with which to manage their disease -- one that offers more flexibility and convenience than traditional insulin therapies."
People with diabetes live with major inconveniences -- they monitor blood glucose levels daily, take medications or sometimes inject insulin several times a day to help their bodies process food. For people who are using regular human insulin, injections currently should be timed at least 30 to 60 minutes before meals to allow the medication to begin working.
A 1995 survey of 453 U.S. insulin-using patients with Type 1 and Type 2 diabetes showed that 43 percent injected insulin right before a meal and did not wait the recommended 30 to 60 minutes before eating. This behavior can increase a patient's risk for hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar), according to survey author Dr. Richard Bergenstal of International Diabetes Centers in Minneapolis.
Humalog may offer people more flexibility. People with diabetes who participated in clinical trials injected Humalog up to 15 minutes before a meal instead of injecting regular human insulin between 30 and 60 minutes before. Clinical trial evidence showed that Humalog acted faster than regular human insulin to control blood glucose levels after a meal. The most common side effect observed in these clinical trials was hypoglycemia for both regular human insulin and Humalog patients.
"Before Humalog, insulin treatment regimens have improved glycemic control but have failed to completely reproduce the action of the body's own insulin," said Bergenstal, a doctor participating in Lilly's Humalog clinical trials. "With Humalog, we are taking a step toward a more physiologic replacement of insulin."
Humalog was discovered and developed by Lilly scientists who found that the time action of insulin could be accelerated by changing the order of two amino acids in the human insulin molecule. Humalog is designed to mimic the body's natural rapid insulin output in response to eating a meal.
Lilly is seeking permission to market Humalog in other countries around the world, including the Asia-Pacific region, Canada, Japan, Latin America and New Zealand. The company already has received approval to market the insulin analog in 15 European Union member countries, Australia, Russia, South Africa, Switzerland and the Czech Republic. The product is being sold in Russia, Switzerland, South Africa, Germany, the United Kingdom and Sweden. Other launches are expected in coming weeks and months in countries where the drug has been approved for sale.
On Feb. 29, 1996, the U.S. FDA Endocrine and Metabolic Drug Advisory Committee unanimously recommended that the FDA approve Humalog for marketing. With the FDA's approval, Lilly expects to begin selling Humalog as a prescription product to U.S. customers in August.
Lilly was the first company in the world to get permission to market a human insulin analog when Russia's Ministry of Health approved Humalog. Other company firsts include commercializing the first insulin product derived from animal pancreases in 1923, and bringing to market the first human insulin of recombinant DNA origin in 1982.
Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering superior health care solutions -- by combining pharmaceutical innovation, existing pharmaceutical technology, disease prevention and management and information technologies -- in order to provide customers worldwide with optimal clinical and economic outcomes. Endocrine diseases are one of five therapeutic areas in which the company is focusing its efforts.
Humalog® (insulin lispro [rDNA origin], Lilly)
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